MDSAP Audit Approach (MDSAP AU P0002) C5-T1: Identify which devices are subject to design and development controls in each jurisdiction and maintain the technical documentation evidence they require

What does C5-T1 require?

The organisation must identify the devices that regulations make subject to design and development procedures. Australia: manufacturers using the full quality assurance procedure (Sch 3 Pt 1) must have design and development procedures, and for every class the Annex 1 technical documentation expectations apply. Brazil: there is no exemption from design control, and where design is outsourced the manufacturer must hold the complete device master record and design transfer records (RDC 665/2022 Arts 52 and 63). Canada: for Class II devices not under design control, there must be objective evidence that they satisfy CMDR 10 to 20 on safety and effectiveness. Japan: Class 1 devices are exempt from the design requirements of MO169 Arts 30 to 36-2. United States: Class II and III devices, and Class I devices automated with software plus the listed Class I types (tracheobronchial suction catheters, non-powdered surgeon's gloves, protective restraints, manual radionuclide applicators, radionuclide teletherapy sources) must meet ISO 13485 clause 7.3. Clauses: ISO 13485:2016 4.1.1, 4.2.1, 7.1, 7.3.10; TG(MD)R Div 3.2; 21 CFR 820.10(c).